The present invention relates to a method of treatment for allergic rhinitis, "sinus headaches," viral nasopharyngitis, and other afflictions of the sino-nasal area associated with nasal congestion.
The discomfort associated with nasal congestion is substantial, and the headache produced when the congestion occludes the openings of the paranasal sinuses into the nasal cavity can be unbearable. Besides severe pain, the occlusion of these openings can lead to the inoculation of the occluded congested tissues with bacteria. This can lead to acute abscesses of the sinuses and to chronically infected sinuses which may lead to progressive asthma and respiratory insufficiency as well as pain and disability. Clearly a safe and effective means of reducing the congestion of these tissues and preventing the cycle of disease that might result is needed.
The traditional methods for the treatment of allergic rhinitis and nasal congestion all have well known side effects. Antihistamines cause drowsiness and can impair judgment in the use of automobiles and other machinery. Decongestants, and adrenalin derivatives, may elevate blood pressure, cause palpitations of the heart and impair the patient's ability to sleep. Topical vasoconstrictor nasal preparations allow a rebound phenomenon as they wear off, resulting in increased nasal congestion. In the long-acting form, topical vasoconstrictors can cause an atrophic thinning of the lining tissues of the nose if topical nasal treatment is continued over too long a period.
There are also two classes of prescription topical nasal preparations available: (1) adrenal steroids and (2) cromolyn sodium solution. Adrenal steroid ("cortisone") derivatives are effective. On long term use, however, they result in a fragility of the tissues to which they are applied which results in bleeding and a propensity to yeast infections. Cromolyn sodium solution is expensive but also effective for many although not all cases of nasal congestion.
With an understanding of the limitations of the available treatments for nasal congestion, it is apparent that an inexpensive method of treatment which does not have local and systemic toxic effects, would provide a novel and beneficial addition to the available therapeutic treatments. The benefits would be even more apparent if the treatment would, in addition, provide relief for those patients who are not helped by the traditional modalities of treatment, their side effects notwithstanding.
Ascorbic acid (Vitamin C) is a well-known organic chemical. It is stable in dry form although it is sensitive to heat (leading to oxidation) and there is a gradual darkening of the solid on exposure to light. It is also sensitive to acids and alkalis when in solution and is known to deteriorate rapidly in the presence of copper, iron and silver. There have been numerous claims that when taken orally, Vitamin C is effective in the prevention of viral nasopharyngitis ("the common cold"), but test results have been inconclusive on this point. Similarly, there have been claims made for its efficacy in the prevention of certain forms of bronchial asthma when taken orally. These claims were not substantiated, however, when ascorbic acid was given intravenously before allergic inhalation challenges. Thus, the actual efficacy of ascorbic acid in treating these conditions, and the mechanism by which the observed effects are produced, is unclear.
There are several patents relating to the topical use of ascorbic acid (U.S. Pat. Nos. 3,954,989; 3,920,848; 4,424,232), which refer specifically to the application of a combination of substances including Vitamin C to the skin. These patents relate to the soothing, anesthetic or healing properties of combinations including ascorbic acid. None of these patents, however, provides for the application of the ascorbic acid to the nasal mucous membrane and none makes reference to the anti-allergic or topical decongestant effect of ascorbic acid on IgA secreting mucous membrane.